ValGenesis, one of the leaders in paperless validation solutions, announced that its VLMS (Validation Lifecycle Management System) supports AR for hands-free and remote validation, to enhance efficiency, compliance, and data integrity in the corporate validation process.
At the time validation and qualification in clean and aseptic manufacturing facilities, technicians can spontaneously locate and view work instructions, protocol test steps with just a voice command to the AR wearable device. All rules details are captured by recording results and objective evidence like videos and photos with natural voice commands. This comprehensive hands-free validation process is compliant with FDA 21 CFR Part 11 & Annexure 11.
Some of the functions provided by the augmented reality app in ValGenesis VLMS:
- Remote specialist support through Microsoft Teams: Remote support functionality allows validation SMEs (Subject Matter Experts) to pull in an employee when their expertise is needed. This includes real-time chats, on-demand video calls, and the capacity to share images from the expert.
- Total hands-free validation: Validation performance activities can be remotely controlled in cleanrooms and aseptic manufacturing plants. The employee operating the hands-free device does not need a laptop or tablet as the device captures and records all the data via the AR device.
- Guided validation processes: Uses electronic work instructions to guide validation SMEs and to make sure compliance with regulatory requirements and allowing standardization.
“ValGenesis VLMS has been trusted by several global life science companies for paperless validation and is the system of record for their corporate validation processes. ValGenesis is committed to continual improvement, and as part of this commitment, continues to evolve its offerings in line with the evolving needs of its customers and the ever-changing regulatory requirements, technology landscapes, and business environments. In collaboration with our current clients, ValGenesis continues to build its leadership position for its Validation Lifecycle Management System, which is being recognized as the de-facto standard for supporting a paperless validation lifecycle process. ValGenesis now offers an innovative AR solution to help clients improve the efficiency of the validation process while ensuring compliance and data integrity,” – Dr. Siva Samy, CEO and Chief Product Strategist at ValGenesis Inc.